BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONATE EL ICD VR

    MDR report key: 23174194 · Received September 29, 2025

    Report

    Report Number
    2124215-2025-68638
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    July 30, 2025
    Report Date
    September 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P960040/S385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE CONCERNS THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) TO THE PATIENT. THERE WERE CONCERNS THERE WERE SENSING ISSUES. X-RAY IMAGING WAS PERFORMED. TECHNICAL SERVICES (TS) IS TO REVIEW THE REPORTS. THE DEVICE REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATES THE SENSING ISSUES WERE OVERSENSING OF ATRIAL SIGNALS ON THE VENTRICULAR CHANNEL. ADDITIONALLY, THE HEALTH CARE PROFESSIONAL (HCP) IS PLANNING ON REPROGRAMMING THE DEVICE AND PROVIDING THE PATIENT WITH MEDICATION TO SLOW DOWN THEIR INTRINSIC ATRIAL RHYTHM. TS REVIEWED THE REPORTS AND PROVIDED TROUBLESHOOTING ACTIONS. THE DEVICE REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409361 RESONATE EL ICD VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS BOSTON SCIENTIFIC CORPORATION D432 342307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown